New ISO 9001:2000 Interpretations

ISO Technical Committee 176 established a web site for ISO 9001:2000 interpretations at <http://www.tc176.org/Interpre.asp>. Their initial set of 14 interpretations were included in our January 2004 newsletter. The ISO 9001:2000 interpretations added since that time are shown below. 

ISO 9001:2000 Interpretation RFI – 026
Request: ISO 9001:2000 Clauses: 4.2.2 c) and 4.1 b)
Does Clause 4.2.2 c), require that the manual include a description of the processes, in addition to a “description of the interaction between the processes of the QMS ”?
Background: Attention is also drawn to the connection between Clause 4.2.2 c) and Clause 4.1 b), where the organization is required to “determine the sequence and interaction” of the processes. On this problem of interpretation there is a divergence of opinion between an organization and a Certification Body.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 001
Request: ISO 9001:2000 Clause: 4.2.3 a)
Does documented purchasing information that is part of the quality management system, have to be approved according to 4.2.3 a)?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 004
Request: ISO 9001:2000 Clause: 4.2.3 a)
Do documented inspection and test procedures that are part of the quality management system, have to be approved according to 4.2.3 a)?
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 021
Request
: ISO 9001:2000 Clause: 5.4.2
Is it a requirement of Clause 5.4.2 to have a document that describes the objectives, timeframe, action and responsibilities? (Note: The description of this document is not the same as the definition of “Quality Plan” in ISO 9000:2000, paragraph 3.7.5)
Background: Some users interpret Clause 5.4.2 of the standard to require a document (quality plan) that describes the objectives and the responsibilities etc. This is in addition to the quality manual and procedures document already established to control the relevant processes.
Interpretation: No

ISO 9001:2000 Interpretation RFI – 003
Request
: ISO 9001:2000 Clause: 6.3
Does Clause 6.3 require records of the maintenance of infrastructures?
Interpretation: No

ISO 9001:2000 Interpretation RFI – 022
Request: ISO 9001:2000 Clause: 7.1
Does the use of the word “form” in the last sentence of this clause, mean that the output of the planning process must be documented?
Background: There has been some confusion due to the word “form” being interpreted as meaning “document used to record data”.
Interpretation: No
Rationale: The word “form” means usual/suitable format.

ISO 9001:2000 Interpretation RFI – 009
Request: ISO 9001:2000 Clause: 7.2.1 a) 
Does the word “specify” or “specified” quoted in various clauses require documentation? Clauses 7.2.1 a) and b), 7.3.3 d), 7.3.6 and others.
Interpretation: No
Rationale: A relevant example to support the answer is in the definition of procedure (ISO 9000:2000, 3.4.5), “specified way to carry out an activity or process (3.4.1)”, with “Note 1 Procedures can be documented or not”.

ISO 9001:2000 Interpretation RFI – 002
Request: ISO 9001:2000 Clause: 7.4.3
Does Clause 7.4.3 require records of the verification of purchased product?
Interpretation: No

ISO 9001:2000 Interpretation RFI – 039
Request
: ISO 9001:2000 Clause: 7.6 a) 
Clause 7.6 a) states: “Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.” Can the word “OR” in the phrase “be calibrated or verified at specified intervals….” be interpreted as meaning that these two activities are always mutually exclusive?
Background: According to the concept of metrological confirmation established in ISO 10012:2003 (e.g. Figure 2 Metrological confirmation process for measuring equipment) for carrying out verification activities, it is indispensable to define the measuring equipment metrological requirements, and the latter are compared against the results of calibration activities.
Interpretation: No
Rationale: Calibration and verification can both be applicable depending on the situation.

ISO 9001:2000 Interpretation RFI – 034
Request: ISO 9001:2000 Clause: 8.2.1 
In the situation described in the background information, does the standard require an organization to consider also the end user as a customer for monitoring satisfaction?
Background: An organization designs and manufactures a product to its own specifications and sells it to end users through a distribution chain. It is not technically modified between the organization and the end user. The end user can identify the organization through the use of a brand name or a trademark. The organization has contracts with distributors, which in turn sell to stores where end users buy the product.
Interpretation: Yes

ISO 9001:2000 Interpretation RFI – 016
Request: ISO 9001:2000 Clause: 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 a)), does the standard require that the organization inform the customer of the nonconforming product?
Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding the nonconforming product.

ISO 9001:2000 Interpretation RFI – 017
Request: ISO 9001:2000 Clause: 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “statutory and regulatory requirements related to the product” (Clause 7.2.1 c)), does the standard require that the organization inform the competent authority of the nonconforming product? Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding nonconforming product.

ISO 9001:2000 Interpretation RFI – 024
Request: ISO 9001:2000 Clause: 8.5.1
Does the continual improvement of the QMS required by Clause 8.5.1 also cover the “improvement of the product related to customer requirements” required by Clause 5.6.3 b) to be included as an output of the management review?
Background: Clause 5.6.3 mentions in bullet a), the improvement of the “effectiveness of the quality management system” and adds, in bullet b), the “improvement of the product related to customer requirements”. Clause 8.5.1 requires only the “improvement of the effectiveness of the quality management system”, with no mention to the “improvement of the product related to customer requirements”.
Interpretation: No